Autism Spectrum Disorder
Conditions
Interventions
This is a clinical study randomized, double blind, placebo controlled. The target sample is one hundred patients. The patients will be divided into two groups, a group with metabolic syndrome and with
Sponsors
Universidade Federal de São Paulo UNIFESP
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Sex/Gender
Male
Age
10 Years to 16 Years
Inclusion criteria
Inclusion criteria: Patients with Autism Spectrum Disorder diagnosed according to the diagnostic criteria defined in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders; male gender; aged between ten and sixteen years and eleven months; patients using antipsychotic medication for at least one month; patients with mild intellectual disability with a global intelligence quotient between sixty nine and fifty or moderate intellectual disability with a global intelligence quotient between forty nine and thirty five
Exclusion criteria
Exclusion criteria: Patients who modified or discontinued psychotropic medication during the study; patients currently using melatonin or having used it within the last month; patients currently using medications from the beta blocker class and or currently using any benzodiazepine; patients diagnosed with amaurosis; patients diagnosed with early puberty; patients diagnosed with type one diabetes and or hypothyroidism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Improvement in metabolic parameters is expected in patients who received melatonin compared to the placebo group, as verified by the analysis of clinical and laboratory tests including total cholesterol, non high density lipoprotein cholesterol, low density lipoprotein, very low density lipoprotein, high density lipoprotein, triglycerides, fasting glucose, glycated hemoglobin, and insulin, based on the observation of a variation in relation to the normal range limits in pre and post intervention measurements;Outcome found 1: A broad and diverse insulin response was observed post intervention. A statistically significant reduction in systolic blood pressure was observed in the melatonin group. Statistically significant increases were observed in the following parameters total cholesterol, very low density lipoprotein, non high density lipoprotein cholesterol, and low density lipoprotein cholesterol in the melatonin group post treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected | — |
Countries
Brazil
Contacts
Public ContactEliete Buratto
Universidade Federal de São Paulo UNIFESP
Outcome results
None listed